{"id":"tol2506","safety":{"commonSideEffects":[{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Injection site reaction"},{"rate":null,"effect":"Testosterone surge (initial)"},{"rate":null,"effect":"Decreased libido"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"TOL2506 is a sustained-release depot formulation of leuprolide, a GnRH agonist that initially stimulates and then suppresses gonadotropin secretion, leading to sustained suppression of testosterone production. This mechanism is utilized in the treatment of hormone-dependent conditions such as prostate cancer and endometriosis, where prolonged testosterone suppression is therapeutically beneficial.","oneSentence":"TOL2506 is a long-acting leuprolide acetate formulation designed to suppress luteinizing hormone and testosterone levels.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:39:14.743Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced prostate cancer"},{"name":"Endometriosis"}]},"trialDetails":[{"nctId":"NCT04906395","phase":"PHASE3","title":"Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tolmar Inc.","startDate":"2021-07-01","conditions":"Breast Cancer","enrollment":250},{"nctId":"NCT05645536","phase":"PHASE3","title":"Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study","status":"ENROLLING_BY_INVITATION","sponsor":"Tolmar Inc.","startDate":"2022-12-28","conditions":"Breast Cancer","enrollment":250}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"TOL2506","genericName":"TOL2506","companyName":"Tolmar Inc.","companyId":"tolmar-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"TOL2506 is a long-acting leuprolide acetate formulation designed to suppress luteinizing hormone and testosterone levels. Used for Advanced prostate cancer, Endometriosis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}